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Activity Number:
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240
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Type:
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Contributed
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Date/Time:
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Tuesday, August 5, 2008 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301420 |
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Title:
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Decision Rules in Phase II and III Oncology Studies
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Author(s):
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Pralay Mukhopadhyay*+ and Thomas Kelleher
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Companies:
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Bristol-Myers Squibb Company and Bristol-Myers Squibb Company
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Address:
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5 Research Pkwy, P.O. Box 5100, Wallingford, CT, 06460,
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Keywords:
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Randomized trials ; futility ; PET
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Abstract:
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Randomized phase II trials are becoming more common in oncology drug development. Such studies provide useful information on efficacy and safety in the context of a comparator and help in making better decisions for future development of the drug. Even though randomized phase II trials are helpful, larger phase III studies are often launched without adequate information on efficacy and safety of the drug. In this paper we investigate sample sizes that will be required in a randomized phase II setting (with similar endpoints as phase III) to adequately rule out lack of benefit. Using the decision rules from phase II as futility boundaries in the phase III setting we investigate through simulations the loss in power and probability of early termination (PET) compared to running a separate phase II study.
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